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FDA Drug Application 019734 by CHIESI USA INC

Application Number019734
Application Type New Drug Application
Sponsor ApplicantCHIESI USA INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/30/1992N       
AP011/20/1992SCS       
AP05/12/1995SCM       
AP04/10/1995SCS       
AP04/29/1997SCM       
AP010/24/2002SCS       
AP06/22/2007SLR16898009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019734s009ltr.pdf 7/5/2007
AP07/31/2008SCF20497013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019734s013ltr.pdf 8/5/2008
AP011/7/2008SCF21220014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019734s014ltr.pdf 11/13/2008
AP01/13/2010SLR24514015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019734s015ltr.pdf 1/15/2010
AP01/13/2010SLR24551015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019734s015lbl.pdf 1/20/2010
AP02/7/2011SLR27761017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019734s017lbl.pdf 2/7/2011
AP02/7/2011SLR27766017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019734s017ltr.pdf 2/9/2011
AP05/2/2013SCM       
AP09/27/2013SCM       
AP04/30/2014SCM       
AP07/23/2014SLR39977023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019734s023lbl.pdf 7/24/2014
AP07/23/2014SLR39994023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019734Orig1s023ltr.pdf 7/24/2014
AP012/2/2014SCM       
AP05/21/2015SCM       
AP012/21/2015SCM       
AP08/26/2016SLR46900027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019734Orig1s027ltr.pdf 8/29/2016
AP08/26/2016SLR46909027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019734s027lbl.pdf 8/29/2016




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